As “toxic sex toys” are being talked about more and consumers and retailers are slowly being educated more, the idea of the “novelty use only” tagged sex toys is being held up as the poster child for all the is bad and wrong in the sex toy industry. But I learned something when I started talking to companies – some of them just don’t know jack shit. They’re doing it because there are no legalities or formal ways to do things, there is no governing body or regulations of any kind. Some companies are taking tentative steps out on a limb and doing away with the wording of “novelty” in any fashion; some get more creative and legal with their warnings. Some companies still use the term….companies that we have come to trust and respect. One such example is Standard Innovations, the Canadian company responsible for the We-Vibe family of vibrators (and my beloved Salsa/Tango). They are regarded as a company who only produces body-safe sex toys; “luxury” sex toys. Their vibrators are made of silicone or hard ABS plastic. They are clearly not a “joke” vibrator, they are clearly meant to be used for sexual purposes. Below is a disclaimer from Evolved Novelties that comes from a pack of their Vibrator Enhancer add-ons (since those are just a hunk of silicone, it’s clear the disclaimer is their stock one), the one from the We-Vibe Salsa, and the one from the Jopen Intensity. Hover over the thumbnails to read the full disclaimer.

But they’re not exactly denying the sexual part of usage in their disclaimer. They are contradicting themselves, sometimes, by telling you to use it externally only in the disclaimer (after giving explicit directions to insert it in to your body, like Jopen did with the Intensity as seen here). I’ve yet to run across a disclaimer that outright says : “This is not for sexual use”; they’re denying a medical use: “not a medical device, it is designed for pleasure only. No therapeutic benefits are claimed” is one that I’ve seen. I think it’s akin to the warnings on bottles of herbal remedies like taking Turmeric pills for inflammation – “these statements have not been proven by the FDA”. Does this mean that Turmeric is bunk, that it will have no chance of reducing inflammation? Nope. Just that big company pharmaceuticals is where the money is at, and where all the testing goes. The redirect of language to avoid trying to look like a “medical device” is simply to avoid getting in to bed with the FDA when it comes to exporting since, as we’ve learned, a large percentage of vibrating sex toys are produced in China or Japan. After receiving some “blowing smoke up my ass” responses from a few companies, I contacted Jopen. I know that they’re a division of California Exotic Novelties1 but I still see them as a little bit separate since the designs for most of their items come from a company called Swan. However, the blunt response I outright asked, nay, begged for came back from Al Bloom of CalEx:

Actually, it is quite simple. To avoid being classified as a medical device by the FDA, we have to make a clear distinction in our labeling that our products are strictly for pleasure, and not a medical device of any type. Once pleasure products fall under the auspices of the FDA, the thousands of choices that consumers enjoy today, at prices they can afford, would dry up, and they would be left with a handful of very expensive products that weathered the storm of FDA testing, retesting, and multiple fees and costs along the way.

Listen, we support FDA testing and protections on consumables, medications, and actual medical devices, but when it intrudes into the bedroom, the consumers will end up losing choice, affordability, and a whole lot of varied degrees of fun!

Now, please understand that because we are classified as pleasure products, and labeled as novelties, does not mean that we disregard safety issues regarding our products. In fact, we go overboard in this area. We use only body safe materials, and our motors and internal wiring conforms to the strictest testing using European Union guidelines for RoHS and WEEE.

I respect him for this answer. I may hate 99% of the stuff that CalEx puts out and feel that they still produce toxic toys and I may now be feeling that Jopen is a highly overpriced trainwreck, but I still respect Al as a person for telling me this stuff. When I asked for clarification about the tariff rates as I mentioned in my first post, he responded:

Yes, US Customs classifies medical devices at a much higher tariff rate than pleasure products. That is not our main concern, it’s really the hoops you mention…and, it can take years to get a product through FDA testing, a huge stumbling block to get over.

He’s not exaggerating – a friend told me about the piles of paperwork, the fees and the hoops and the time that someone had to go to to get a sexual lubricant FDA-approved. Now, they can still use FDA-Approved materials, and make that claim. That doesn’t necessarily mean that, for example, Lelo went to the trouble of getting their silicone FDA approved. It means that their material supplier did, and they can carry that certificate on themselves to inform their customers (to the best of my knowledge, and practice assumptions are gleaned based on facts derived from a company I’ve done work for that does work for medical companies – they have to use medically-approved supplies but they don’t have to get the FDA approval, the supplier of those materials does). Interested in what Lelo had to say? I’ve annotated it with comments from my anonymous friend to decipher the smoke-blowing:

As all LELO products are made of 100% body-safe, FDA-approved2 materials3, we have never used the word “novelty” on any of our packaging, so this part of your inquiry does not really apply to us. It is good you are bringing this issue to attention on your blog though, as consumers should realize that the word “novelty” on sex toy packaging can sometimes serve as a legal loophole4, since the materials may not necessarily be body-safe certified5. It is best for consumers to always research a company’s reputation online, ask questions to in-store sales representatives, seek advice from bloggers like yourself, etc.

Yes LELO is manufactured in China, but the thing that sets us apart from any company worldwide, is that LELO manufactures all of its products fully in-house6. When we say that we believe in and stand behind our products, it’s not based solely on faith. All of our products are put through a rigorous pre-testing and post-testing regimen to ensure that LELO’s high standards of quality are met. Being the only company in the industry to manufacture products fully in-house7, we are able to keep a close eye on these testing processes. And even after our products have passed our in-house tests, they also go through independent testing agencies like Intertek and SGS to receive official product certification, and to ensure all health and safety requirements have been met8.

Alright so let’s hear from SI/We-Vibe who produce sex toys that I (mostly9) like (even if some don’t work for me) and who do use a disclaimer:

We-Vibe products are labeled, “Sold as an adult novelty. Not for medical use.” Although our products are often found in pharmacies, OB/GYN and therapists offices they are not classified as medical devices and we want to ensure there is no confusion with consumers. Medical devices must meet a host of defined regulatory standards unique to specific jurisdictions. We-Vibe products are designed for pleasure purposes with safety as a top priority. Our products meet or exceed many international standards for consumer electronic products10.

The silicone used in We-Vibe products is sourced from a medical manufacturer and undergoes a series of inspections and quality control processes before it makes its way to our production facilities11. We-Vibe regularly, as often as once a week, conducts manufacturing inspections to ensure our high standards are being met. In addition, our products are routinely inspected by an independent lab to ensure they meet or exceed REACH (the European Community Regulation on chemicals and their safe use), RoHS (an electronics standard to reduce hazardous materials found in electric components) and other international consumer electronic standards12. Body-safe and eco-friendly is not just a stamp on the box – We-Vibe’s primary concern is quality products and consumer safety.

You’ll also want to let your readers know about counterfeit products that are showing up more often and being produced without concern for the health or safety of consumers. Beware of highly discounted product, if a deal seems too good to be true, it’s likely the product may be counterfeit and the safety claims may be questionable. Authentic We-Vibe products are available from authorized distributors and retailers. Consumers should purchase our products from reputable, established and trusted businesses13.

All in all, I’m disappointed with their answer….but yet there are other ways to look at it. First, that they don’t take me seriously. Second, that perhaps they’re shutting the door on a trade secret. Third, that perhaps they just don’t know why they label it that way, but everybody else does/did and they will too. There was not an ounce of facts there that came even close to answering my question. At least Al Bloom answered me without a crap ton of marketing fluffy bullshit. On the other side of the coin, at least they answered. The contact I have couldn’t answer it so they passed it along to someone else internally. Half of the companies I contacted wouldn’t even respond to me.

Okay so what about companies who produce mostly in the US, like Tantus? I know that a few items need to be outsourced. I don’t know which items. Do those items have a more strict disclaimer? Tantus, though, isn’t using “novelty”. In fact their disclaimer on the suction cup is kind of intimidating. I’ve shown the disclaimers below for one of the Secret Vibrators and the Suction Cup. Mouse over the photo to get the text of the disclaimer to pop up if you don’t feel like clicking.

Aneros is also a little concerning, especially (in my opinion) since the item is meant to do prostate stimulation. The butt seems to be just a little bit more ….. sensitive, or maybe that’s just mine. “Disclaimer: Use of Aneros products is at your own risk. Neither the manufacturer nor retailer assumes any responsibility or liability for use of Aneros products” Again, I don’t know if this negates any legal claims if you get hurt. As Davis told us before, they can’t prevent a lawsuit. But it sure will deter the consumer.

I attempted to contact Vibratex, to ask them why they’ve never had to use a disclaimer, but they wouldn’t respond to me even with repeated attempts. I put out an email to Evolved Novelties, but received no reply there, either. I’ll wrap this up with a little bit of industry history courtesy of Metis Black of Tantus:

When the industry was a baby Ted Marche made toys in his garage and he sold them very prolifically. This was the first US large manufacturer. He made a toy that had a wire inside the soft latex which rotated, much like the modern rabbits do. On one toy the interior wire was not capped, the edge of the wire as it was being used inside a man’s rectum chewed through the toy and did severe internal damage to his body. I think this was the mid 70’s. He (Marche) was sued and lost. The judge gave the victim a $14 mil settlement- which of course Mr. Marche couldn’t pay. That is how Ruben Sturman, and later Ron Braverman, got Doc Johnson. He took it off Mr. Marche’s hands.

I don’t know, but I suspect that was the turning point for having a disclaimer on the box. And that is why legal liability is so important in the industry. We are an industry that pays through its teeth for our liability insurance. You never ever have to see a claim and still, because of what we make as an industry, we are charged an arm and a leg and we are told we are lucky to even get it since 99% of insurance companies won’t issue insurance on our products.

I honestly don’t think it has anything to do with the quality, or lack thereof, of a sex toy. I think it has to do with history. Small manufacturers are less likely to use this terminology. Large one’s are more likely.

I’m going to continue to work on this list, with the help of others – if I have something listed incorrectly, let me know and if there’s a brand not listed, let me know how to categorize it. If you see a brand we trust with a disclaimer of any type, can you photograph it and send it to me? It’s going to be a given that the larger and older companies will continue to use the disclaimers.

“‘FDA approved materials’ is nothing more than a clever marketing ploy to confuse consumers into thinking their products are FDA approved”↩

“The fact that they use FDA approved materials has nothing to do with anything. The FDA is concerned with the final product, not the individual materials used, so it has no bearing on importing, costs or otherwise.”↩

“There is no “legal-loophole” and they are perpetuating the spread of misinformation for their own gain.”↩

“Who is the certifying agency of their “body-safe certified” products? I have never heard of such a thing.”↩

“I am assuming this means they have their own factory?” Me: Maybe yes?See this↩

“This is a false statement. They are far from the “only” company manufacturing their own toys. Doc Johnson, Blush Novelties, Odeco (which is also the factory for NS Novelties), IMToy and Maia Toys are also producing their own lines, along with many, many other factories.”↩

“While this is true, what she is not saying is that they HAVE to perform these tests if they want to sell in the EU. There is NO WAY around this and every single toy that has vibration goes through the same testing procedures, no matter what the company (unless they don’t want to sell in Europe). These are the RoHS and CE certification tests. The only question in regards to testing that would be worth asking is WHO does the testing and Intertek and SGS are in fact, the most reputable testing facilities.”↩

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